Postoperative and Opioid Free Anesthesia (POFA)
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|ClinicalTrials.gov Identifier: NCT03316339|
Recruitment Status : Terminated (Sponsor's decision)
First Posted : October 20, 2017
Last Update Posted : October 18, 2019
Since the 1960's, intraoperative administration of opioids is considered a keystone of anesthesia as well as hypnotics and muscle relaxants. Synthetic opioids were introduced to achieve hemodynamic stability during anesthesia. They allow an inhibition of the sympathetic system without cardiovascular collapse and histamine release. Since then, anesthesia has changed from inhalation to multimodal anesthesia with lower doses of hypnotic. In 2017, the intraoperative objectives of hypnosis, hemodynamic stability, immobility and anticipation of postoperative analgesia can be achieved without opioids. Moreover, opioid administration consequences are neither scarce nor benign for the patient. Perioperative opioids are associated with nausea and vomiting, sedation, ileus, confusion/delirium, respiratory depression, increased postoperative pain and morphine consumption, immunodepression, hyperalgesia and chronic postoperative pain. Among these complications, hypoxemia, ileus and confusion/delirium are the most frequent.
Efficacious multimodal analgesia and anesthesia are the basis of successful fast-track surgery. These multidrug regimens aim at decreasing postoperative pain, intra- and postoperative opioid requirements, and subsequently, opioid-related adverse effects and to fasten recovery. Opioid-free postoperative analgesia has been recommended for more than 10 years. Opioid-free anesthesia (OFA) is based on the idea that hemodynamic stability can be achieved without opioids during anesthesia. OFA is multimodal anesthesia associating hypnotics, N-methyl-D-aspartate (NMDA) antagonists, local anesthetics, anti-inflammatory drugs and alpha-2 agonists (Dexmedetomidine).
Proofs of the effect of OFA on reducing opioid-related adverse effects after major or intermediate non-cardiac surgery are still scarce. We hypothesized that the reduced opioid consumption during and after surgery allowed by OFA compared with standard of care will be associated with a reduction of postoperative opioid-related adverse events.
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Opioid-Related Disorders||Drug: Dexmedetomidine Drug: Remifentanil||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||316 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effect of Opioid-free Anesthesia on Postoperative Opioid-related Adverse Events After Major or Intermediate Non-cardiac Surgery: a Multicenter Prospective Randomized Controlled Study|
|Actual Study Start Date :||November 29, 2017|
|Actual Primary Completion Date :||January 29, 2019|
|Actual Study Completion Date :||June 19, 2019|
|Active Comparator: Control||
- Occurence of a severe postoperative opioid-related adverse event defined as : postoperative hypoxemia or postoperative ileus (POI) or postoperative cognitive dysfunction (POCD). [ Time Frame: Within the first 48 hours after extubation ]
Postoperative hypoxemia is defined as an oxygen saturation (SpO2) < 95% with a need for oxygen supplementation within the first 48h after extubation; the duration of oxygen treatment will also be recorded.
Postoperative ileus is defined as an absence of flatus or stools within the first 48h after extubation.
Postoperative cognitive dysfunction will be evaluated using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) by a care provider (either anesthesiologist or nurse).
- Number of episodes of postoperative pain (numeric rating scale ≥ 3), at rest [ Time Frame: Within 48 hours after extubation ]
- Opioid consumption [ Time Frame: During the 48 hours following extubation ]
- Time between the end of remifentanil or dexmedetomidine administration and an Aldrete score > 9 (when applicable) [ Time Frame: Within 48 hours after extubation ]
- Time between the end of remifentanil or dexmedetomidine administration and extubation [ Time Frame: Hour 0 = extubation ]
- Rate of unscheduled admission in intensive care unit [ Time Frame: Within 48 hours after extubation ]
- Number of postoperative nausea and vomiting (PONV) episodes [ Time Frame: During the 48 hours following extubation ]
- Hospital length of stay (max 28 days) defined as the number of days after extubation before first hospital discharge [ Time Frame: Day 28 ]
- Number of bradycardia, hypotension and hypertension events during surgery and number of rescue medications during surgery [ Time Frame: During surgery (maximum duration of 7 hours) ]Bradycardia is defined as the number of episodes with atropine administration. Hypotension is defined as mean arterial blood pressure < 65 mmHg. Hypertension is defined as mean arterial blood pressure > 90 mmHg.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316339
|Clermont-Ferrand University Hospital|
|Lille University Hospital|
|Montpellier University Hospital|
|Nantes University Hospital|
|Nimes University Hospital|
|Rennes University Hospital|
|Toulouse University Hospital|
|Principal Investigator:||Hélène BELOEIL||Rennes University Hospital|